Regulatory Operations & Labeling Specialist

Hologic, Inc.; Newark (DE); On-site; USD 73,000 - 115,000; Full time

Job summary

Hologic, Inc. is seeking a Regulatory Operations & Labeling Specialist to support labeling and regulatory operations across GSS product portfolios.

You will serve as the Labeling representative on cross-functional teams and partner with Regulatory Affairs, Quality, Marketing, Engineering, and other stakeholders to keep labels, IFUs, and related documentation accurate and compliant. You will provide operational support for regulatory submissions, document control, regulatory systems management,

Qualifications

• High School Diploma with 4+ years of related experience, or an Associate Degree with 2+ years, or a Bachelor's Degree with 0-2 years.
• Basic knowledge of QSR and GMP.
• Experience with document control, print publishing, or regulated documentation processes.
• Strong written and verbal communication skills and ability to collaborate with cross-functional teams.
• Ability to manage multiple projects and changing priorities in a fast-paced environment.

Responsibilities

• Support labeling activities for assigned product portfolios.
• Represent Labeling on cross-functional product and project teams.
• Drive labeling requirements for new product development, sustaining engineering, and remediation projects.
• Create and maintain product labels and Instructions for Use (IFUs) using approved templates and document structures.
• Prepare redlines for labeling changes and coordinate stakeholder review and approval cycles.
• Maintain master labeling documents and portfolio baselines to ensure accuracy and consistency.
• Perform label verification activities to confirm compliance, accuracy, and completeness prior to release.
• Manage labeling deliverables through Agile Product Lifecycle Management (PLM) and other document management systems.
• Coordinate translation activities with internal stakeholders and external translation vendors.
• Review translated content against source documentation for formatting, numerical accuracy, and consistency.
• Gather supporting documentation and cross-functional inputs required for change orders and regulatory submissions.
• Prepare, format, and publish regulatory submissions in accordance with applicable health authority requirements and electronic submission standards.
• Maintain regulatory information management systems, ensuring accurate tracking of registrations, licenses, approvals, and submission status.
• Manage regulatory document control activities, including version control, records management, and audit readiness.
• Support compliance with regulatory databases and establishment registrations, including UDI and health authority portals.
• Provide operational support during audits and inspections by retrieving, organizing, and maintaining regulatory documentation.Facilitate compliant review and approval processes for advertising and promotional materials.
• Coordinate cross-functional review workflows to ensure content is appropriately vetted prior to release.
• Maintain records retention for approved promotional materials and associated review documentation, ensuring audit readiness and compliance.
• Manage multiple labeling, regulatory, and documentation projects simultaneously.
• Prioritize competing deliverables and effectively communicate timelines, risks, and project status.
• Support continuous improvement initiatives, including work instructions, templates, style guides, knowledge management resources, and departmental procedures.
• Ensure compliance with applicable quality system requirements, policies, and procedures.

Skills

Communication skills

Cross-functional collaboration

Project management

Multitasking

Education

Bachelor's degree

Associate degree

High school diploma

Tools

Adobe Illustrator

Adobe InDesign

Agile PLM

Job description

Regulatory Operations & Labeling Specialist

Louisville, CO, United States

San Diego, CA, United States

Newark, DE, United States

Marlborough, MA, United States

We are seeking a detail-oriented Regulatory Operations & Labeling Specialist to support labeling and regulatory operations activities across assigned GSS product portfolios. In this role, you will serve as the Labeling representative on cross-functional project teams and partner closely with Regulatory Affairs, Quality, Marketing, Engineering, and other stakeholders to ensure product labels, Instructions for Use (IFUs), and related documentation remain accurate, compliant, and up to date.

You will also provide operational support for regulatory submissions, document control, regulatory systems management, compliance activities, and the review and retention of advertising and promotional materials.

This is an excellent opportunity for professionals with experience in medical device labeling, regulatory operations, document control, print publishing, or regulated product documentation who enjoy managing multiple projects, collaborating across functions, and driving process improvements.

This position may be based in Colorado, Delaware, Massachusetts, or South Dakota.

What to Expect

Key Responsibilities

• Support labeling activities for assigned GSS product portfolios.

• Represent Labeling on cross-functional product and project teams.

• Drive labeling requirements for new product development, sustaining engineering, and remediation projects.

• Create and maintain product labels and Instructions for Use (IFUs) using approved templates and document structures.

• Prepare redlines for labeling changes and coordinate stakeholder review and approval cycles.

• Maintain master labeling documents and portfolio baselines to ensure accuracy and consistency.

• Perform label verification activities to confirm compliance, accuracy, and completeness prior to release.

• Manage labeling deliverables through Agile Product Lifecycle Management (PLM) and other document management systems.

• Coordinate translation activities with internal stakeholders and external translation vendors.

• Review translated content against source documentation for formatting, numerical accuracy, and consistency.

• Gather supporting documentation and cross-functional inputs required for change orders and regulatory submissions.

• Prepare, format, and publish regulatory submissions in accordance with applicable health authority requirements and electronic submission standards.

• Maintain regulatory information management systems, ensuring accurate tracking of registrations, licenses, approvals, and submission status.

• Manage regulatory document control activities, including version control, records management, and audit readiness.

• Support compliance with regulatory databases and establishment registrations, including UDI and health authority portals.

• Provide operational support during audits and inspections by retrieving, organizing, and maintaining regulatory documentation.Facilitate compliant review and approval processes for advertising and promotional materials.

• Coordinate cross-functional review workflows to ensure content is appropriately vetted prior to release.

• Maintain records retention for approved promotional materials and associated review documentation, ensuring audit readiness and compliance.

• Manage multiple labeling, regulatory, and documentation projects simultaneously.

• Prioritize competing deliverables and effectively communicate timelines, risks, and project status.

• Support continuous improvement initiatives, including work instructions, templates, style guides, knowledge management resources, and departmental procedures.

• Ensure compliance with applicable quality system requirements, policies, and procedures.

Required Qualifications

• High School Diploma and 4+ years of related experience; or

• Associate Degree and 2+ years of related experience; or

• Bachelor's Degree and 0-2 years of related experience.

• Basic knowledge of Quality System Regulations (QSR) and Good Manufacturing Practices (GMP).

• Experience with document control, print publishing, design, or regulated documentation processes.

• Strong written and verbal communication skills.

• Proven ability to collaborate effectively with cross-functional teams.

• Ability to manage multiple projects and changing priorities in a fast-paced environment.

Preferred Qualifications

• 4-6 years of experience in labeling, regulatory operations, document control, or a related discipline.

• Proficiency with Adobe Illustrator and Adobe InDesign.

• Experience working within Agile Product Lifecycle Management (PLM).

• Medical device labeling experience, particularly within surgical or interventional product portfolios.

• Experience supporting products throughout the entire lifecycle, from label development through ongoing maintenance.

• Knowledge of change control processes, documentation review workflows, and translation management.

• Familiarity with global regulatory submission requirements and health authority interactions.

• Experience with regulatory information management systems and electronic document management systems.

• Familiarity with advertising and promotional material review processes, including MLR-style review environments.

Why Join Hologic?

At Hologic, our purpose is to enable healthier lives everywhere, every day. We are committed to fostering an environment where talented professionals can grow, develop, and make a meaningful impact.

We provide comprehensive onboarding, ongoing learning opportunities, and career development programs designed to help you succeed. In addition, we offer competitive compensation, comprehensive benefits, and a collaborative culture focused on innovation and continuous improvement.

The annualized base salary range for this role is $73,400 - $114,900 , and the position is eligible for participation in Hologic's bonus program. Final compensation will be based on factors including experience, skills, education, geographic location, and business needs.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current, fully executed Hologic Agency Agreement in place and may only submit candidates to positions for which they have been specifically authorized by a Hologic Recruiter. Resumes submitted outside of these terms will not be considered.

Equal Opportunity Employer

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of individuals with disabilities and protected veterans.

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